Proposed New Standard Being Developed for Ultra- High Molecular Weight Polyethylene with Vitamin E

ASTM International Committee F04 on Medical and Surgical Materials and Devices invites all interested parties to participate in the development of a proposed new standard, WK15544, Test Method for Evaluating the Vitamin E Yield in Ultra-High Molecular Weight Polyethylene Fabricated Forms Intended for Surgical Implants by Infrared Spectroscopy. WK15544 is under the jurisdiction of Subcommittee F04.15 on Material Test Methods.

According Ray Gsell, principal scientist, chemistry, Zimmer, Inc., ultra-high molecular weight polyethylene containing vitamin E is a new material that is being developed and used in the orthopedic industry for particular surface applications. "Vitamin E, being an antioxidant, when added to UHMWPE, helps protect it from oxidation and subsequent mechanical property degradation," says Gsell, who has chaired Subcommittee F04.11 on Polymeric Materials, as well as several task groups within Committee F04.

Gsell says that at least one orthopedic company has already received approval from the U.S. Food and Drug Administration to market UHMWPE material containing vitamin E and that several other companies are believed to be developing their own versions. The proposed standard will be used widely throughout the world as implant manufacturers work to gain approval to market UHMWPE with vitamin E internationally. Gsell says that companies that use ASTM standard F 648, Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants, as well as ISO 5834, Implants for Surgery-Ultra-High-Molecular-Weight Polyethylene, would be the most likely users of the proposed new standard.

Subcommittee F04.15 had good attendance at their first meeting on WK15544 in May, but Gsell says that the subcommittee would like to have even more participation from potential users of the standard. "To develop a standard like this, representation would be helpful from the regulatory bodies of different countries as well as the technical experts from companies that may be associated with processing these materials from the initial powder mixtures to the final device," says Gsell. //